How to prioritise HCV treatment

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1 How to prioritise HCV treatment From the perspective of the medical community Margaret Hellard

2 Declarations NHMRC fellowship Burnet receives infrastructure support from the Victorian Government Gilead Sciences Abbvie

3 Why should I be prioritising HCV treatment? From a slightly confused medical persons perspective Margaret Hellard

4 A medical perspective means that I am putting on my clinical doctor infectious disease specialist hat not my public health or research hat or any other hat I might wear.

5 Direct acting antiviral treatments Over 90% cure Minimal side effects 8-12 weeks duration What s not to like - and which one of my patients doesn t want them? None so far!

6 From a medical perspective my priority is to treat the patient in front of me whoever they are and whatever their circumstances. So if the patient in front of me wants treatment - then that is who I should prioritise Simple my work here is done!

7 Thank you Acknowledgements me!

8 But I suspect that is not the question I was really being asked to address In a setting where there is limited access to care and treatment who should be prioritised? The issue with this question is it is primarily predicated on treatment being expensive and that is not necessarily the situation everywhere in the world and is unlikely to stay that way Also predicated on the idea that growing burden of disease in F3 and F4 and that this must be treated

9 Cost and treatment access Sofosbuvir US$84,000 SOF+LDV US$96,000 Simeprevir US$60,000 but on PBS in Australia Manufacturing costs (excluding R&D) A Hill, and G Cooke Science 2014;345:

10 In a setting where there is limited access to care and treatment who should be prioritised? The issue with this question is it is primarily predicated on treatment being expensive and that is not necessarily the situation everywhere in the world and is unlikely to stay that way Also predicated on the idea that growing burden of disease in F3 and F4 and that this must be treated first

11 Number of deaths/year from selected conditions, million people died in 2010 of viral hepatitis HCV 48% of those deaths Source: Global Burden of Disease Study 2010 Lozano et al, Lancet 2012

12 Growing HCV burden in Australia Sievert W. JGH 2014 ALA report. The economic cost and health burden of liver diseases in Australia. 2013

13 TREATMENT PRIORITIZATION: IAS-USA GUIDELINES Highest Priority F3/F4 Liver transplant Cryoglobulinemia with end-organ damage HCV-related renal disease High Priority F2 HIV HBV Co-existent liver disease Debilitating fatigue Type II diabetes Porphyria cutanea tarda Individuals at high risk of transmitting HCV to others (PWID, MSM, prisoners, hemodialysis, pregnant women, health care workers) 13

14 14 TREATMENT PRIORITIZATION EASL GUIDELINES Treatment should be prioritized F2 F3/F4 Decomp. Cirrhosis HIV or HBV coinfection Liver transplant F0/F1 Clinically significant extrahepatic manifestation Debilitating fatigue (As of 2015) Individuals at risk of transmission (Grade B1) Treatment justified Informed deferral can be considered J Hepatology 2015

15 But what makes something a medical priority Decompensated liver disease Compensated liver disease F3 - stop progression there is no need for ongoing follow up post treatment Young female - wants treatment prior to getting pregnant Young male - wants to be a boxer, join the defence forces.. 62 year old grandparent and want to help look after my grandchildren so that my child can work so that they can live in an area with better schools but is too exhausted 43 years old - injected occasionally when younger and stopped long ago wants to get rid of hepatitis C because constantly worrying and can t sleep. Know most people progress slowly but it was 20 years ago and could I deteriorate suddenly. Three young children. Person who injects drugs but just wants to get rid of the virus and promises never to share stuff ever ever again Person who injects drugs - and going through a pretty hectic phase but want treatment doc!

16 So I shall now remove my medical hat lets look at this from a broader public health perspective.

17 Post-2015 Development Agenda Sustainable Development Goals (SDGs) Goal 3. Ensure healthy lives and promote well-being for all at all ages 3.3 By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases Universal health coverage - another key component of the SDGs - achieved when all people receive the health services they need, which are of sufficient quality to make a difference, without those people incurring financial hardship.

18 Vision: A world where viral hepatitis transmission is stopped and everyone living with hepatitis has access to safe, affordable and effective care and treatment. Goal: Eliminate viral hepatitis as a major public health threat by 2030.

19 New cases of chronic HCV infections - 80% decline

20 Hepatitis C deaths 65% reduction

21 Achieving the 2030 targets Diagnosis 90% of chronic infections diagnosed Treatment 80% of eligible persons with chronic HCV - treated Harm reduction Number of sterile needles and syringes provided per person who injects drugs per year - increase from 20 to 300. Estimated to be 75% coverage No specific number for increasing coverage for opioid substitution therapy

22 DYNAMIC HCV TRANSMISSION MODEL New PWID Uninfected PWID Allow for re-infection Spontaneous clearance Antiviral treatment Non-SVR infected PWID Chronically infected PWID Cease/die Infection Acutely infected PWID Martin et al. J Hepatology 2011; J Theoretical Biology 2011

23 Prevention impact results: prevalence reductions at 10 years Martin et al. J Hep 2011

24 Access to care Possibly a more telling issue is that many health services are not well structured to provide treatment to large numbers of people - even if treatment was affordable Perhaps tertiary hospital clinicians should be prioritising their time ensuring that treatment is moved to setting to ensure access to large numbers of people mentoring, shared care, political pressure, advocacy Stop stigma and discrimination against key populations particular current and former people who inject drugs Also the cost of testing is high and often not easily accessible need to push this along Lack of approved point of care and rapid tests for HCV

25 How to prioritise HCV treatment From the perspective of the medical community Treat the patient in front of you, or in front of your nurse or the primary care practitioner you support or via telehealth Make sure you have a system of providing health care that mean all patients can be in front of you.

26 Acknowledgements Burnet Institute Rachel Sacks Davis, Emma McBryde, Joe Doyle, Nick Scott St Vincent s Hospital Alex Thompson Bristol University and UCSD Peter Vickerman and Natasha Martin

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